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  • Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more
    The FDA published briefing documents ahead of advisory committee meetings for therapies from Capricor Therapeutics and Replimune indicate an uphill battle for the biotechs; GSK and AstraZeneca outl…
    BioSpace · 6h ago↗ source
  • ‘We have what we need to grow:’ Biogen CEO happy to ease off the M&A for a while
    Biogen's business development team may have been busy in recent years, but CEO Christopher Viehbacher is easing off the acquisitions for a while.
    Fierce Biotech · 6h ago↗ source
  • Novo Nordisk fails to dismiss lawsuit over CagriSema readout
    Novo Nordisk’s attempt to dismiss a lawsuit about its CagriSema readout has failed, with the judge ruling that parts of the investors’ argument were strong enough for the case to proceed.
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Fierce Biotech · 6h ago
↗ source
  • Processa acquires Vidya for potential BTK inhibitor rival to Novartis’ Rhapsido
    Processa Pharmaceuticals has made a push into the autoimmune space via the acquisition of Vidya Therapeutics, which delivers a potential rival to Novartis’ Rhapsido.
    Fierce Biotech · 7h ago↗ source
  • ‘Reverse mergers are increasingly popular’: Caldera hops on Synlogic’s Nasdaq listing
    Caldera Therapeutics has struck a reverse merger with the publicly traded Synlogic and inked a $278 million financing deal, continuing the meteoric rise of the inflammatory bowel disease startup.
    Fierce Biotech · 8h ago↗ source
  • Vertex’s latest autoimmune TCE play involves $28M upfront to AbCellera
    AbCellera’s T-cell engager platform has reeled in a second client this summer, with Vertex paying $28 million upfront for a collaboration that will include autoimmune conditions.
    Fierce Biotech · 9h ago↗ source
  • Visa time limits on foreign Ph.D. students and postdocs will harm U.S. science, experts warn
    A Trump administration plan to limit visas for graduate student and postdocs to four years is fueling concerns that the U.S. could lose out on foreign scientists
    STAT · 1d agoApprovalPositive↗ source
  • FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm
    The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s Duchenne muscular dystrophy cell therapy.
    BioSpace · 1d agoApprovalPositive↗ source
  • STAT+: Preliminary trial results suggest a path to a safer Alzheimer’s treatment
    ProMIS Neurosciences is trying to design a safer amyloid-clearing drug for Alzheimer's. Early results suggest it might be on to something.
    STAT · 1d agoApprovalPositive↗ source
  • GSK shares rise as $2.5B cost-cutting plan unveiled
    As GSK records $2.4 billion in impairment charges for the second quarter, the U.K. pharma has announced a sweeping restructure designed to save about the same amount of money over the next few years.
    BioSpace · 1d agoLayoffsNegative↗ source
  • Boston Scientific unveils major restructuring, plots job cuts amid savings drive
    Medical device maker Boston Scientific has been a prolific dealmaker this year but is now taking a step back as it looks to make changes internally.
    Fierce Biotech · 1d agoLayoffsNegative↗ source
  • As pharma descends on China for deals, BIOSECURE Act raises intellectual property risk
    When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
    BioSpace · 1d agoDealNeutral↗ source
  • Webinar: Building the Intelligence Engine for Drug Discovery R&D Teams
    Drug discovery teams have more data than ever, but turning that data into actionable insight remains a major challenge. In this candid conversation, Patsnap’s Ben Coverdale is joined by Mark Davies…
    BioSpace · 20h agoRegulatoryNeutral↗ source
  • Six key issues we’re watching at Fauci’s hearing
    Sen. Rand Paul is forcing Fauci to appear before his Senate panel.
    STAT · 21h agoRegulatoryNeutral↗ source
  • FDA reminds investors about the risks of advisory panels
    Two days, two similar briefing documents and two companies with diving share prices. The FDA this week laid out its concerns with clinical data from both Capricor Therapeutics and
    Endpoints · 22h agoRegulatoryNeutral↗ source
  • FDA offers updated guidance for generics of weight loss blockbusters
    The FDA revised its draft guidance for generic companies looking to develop copycats of some of the world's best-selling weight loss drugs, including Eli Lilly's Zepbound and Novo Nordisk's Ozempic…
    Endpoints · 23h agoRegulatoryNeutral↗ source
  • STAT+: Bracing for another Fauci hearing
    Plus: Democrats take on Trump over IVF, and Trump's White House releases a new science funding blueprint.
    STAT · 1d agoRegulatoryNeutral↗ source
  • FDA staff say Replimune's melanoma trial failed to prove RP1 works
    FDA staff threw cold water on Replimune’s advanced melanoma drug ahead of a critical meeting with agency advisors, writing that the pivotal study design failed to prove its drug actually works. The…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • The future of gray-market peptides
    Two days’ worth of debate among FDA advisory committee members and agency staff over whether compounding pharmacies should be able to make seven different peptides left me with some big ...
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • STAT+: GSK lays out plans to cut costs, pursue more late-stage drug trials
    New GSK CEO Luke Miels outlined his strategy to help the company navigate a patent cliff and get on a path toward long-term growth.
    STAT · 1d agoRegulatoryNeutral↗ source
  • STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment
    Regulators at the FDA have reiterated concerns that Replimmune does not have adequate data to support an approval of its investigational skin cancer treatment.
    STAT · 1d agoRegulatoryNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and more
    The FDA said a Capricor stem cell treatment for Duchenne muscular dystrophy did not meet a Phase 3 trial's objectives — contrary to company claims
    STAT · 1d agoRegulatoryNeutral↗ source
  • STAT+: Three questions with Whoop’s new CMO
    In this edition of STAT Health Tech: A chat with Whoop's new chief medical officer, an update on CMS health tech initiative, and more.
    STAT · 1d agoRegulatoryNeutral↗ source
  • Altimmune rises as GLP-1/glucagon drug curbs heavy drinking in mid-stage study
    Pemvidutide showed a “highly statistically significant” treatment effect in patients with alcohol use disorder. Altimmune is going up against Eli Lilly and newcomer Baseline Therapeutics, among oth…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Anthony Fauci’s pandemic-era diary entries
    New data on American substance use, concerns of a global HIV resurgence, and more health news from Morning Rounds
    STAT · 1d agoRegulatoryNeutral↗ source